Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma

This is an interventional treatment trial for Asthma Read More

Inclusion Criteria:

• Written informed consent.
• Male or female from 18 to 50 years of age.
• Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.
• Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L.
• Stable asthma therapies.
• Spirometry (pre-bronchodilator) with best FEV1 ≥ 70% of the predicted value.
• Spirometry with reversibility in FEV1 of ≥ 12% and ≥ 200 mL.
• Asthma Control Test™ (ACT) score ≤ 19.

Exclusion Criteria:

• Former smoker with > 10 pack year history or current smoker.
• Patient with a urine level of cotinine ≥ 500 ng/mL.
• Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
• Patient who received allergen immunotherapy for HDM within the past 10 years.
• Ongoing immunotherapy for an aeroallergen other than house dust mite.
• Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
• Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
• Pregnant women or breast-feeding/lactating.
• Women with childbearing potential who are not using a medically accepted birth control method.
• Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in, or the outcome of this study.